BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, RIGHT, 5+17-HOLES, WITH TEMPLATE

    MDR report key: 6800418 · Received August 17, 2017

    Report

    Report Number
    0008010177-2017-00213
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 20, 2017
    Report Date
    April 18, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES OF THE CT SCANS (DATED (B)(6) 2017) AND FURTHER IMAGES WERE PROVIDED BY THE CUSTOMER. ALTHOUGH IMAGES ARE PROVIDED, A CONFIRMATION OF THE EVENT ¿BREAKAGE-POSTOPERATIVE¿ COULD NOT BE VERIFIED, SINCE NONE OF THE GIVEN IMAGES SHOW THE PLATE IN A FRACTURED CONDITION. ALL PROVIDED INFORMATION WERE FORWARDED TO STRYKER¿S SR GLOBAL MEDICAL DIRECTOR. HE STATED: THE SURGEON USED THE WRONG PLATE. THIS OPERATION WAS A SECONDARY RECONSTRUCTION AND HE USED A PRIMARY RECONSTRUCTION PLATE. DOCUMENTED BY PHD M. LANSER, SR GLOBAL MEDICAL DIRECTOR, FOR (B)(4) ON (B)(6) 2018. FURTHER, IN THE INSTRUCTIONS FOR USE, IT IS STATED THAT: PRIMARY RECONSTRUCTION PLATES (GOLD COLOR) ARE NOT INTENDED FOR USE IN SECONDARY RECONSTRUCTION APPLICATIONS. ALSO, IN THE RELATED BROCHURE, LEIBINGER UNIVERSAL 2 (9410-400-184, 2011), IT IS STATED THAT PRIMARY RECON PLATES (COLOR-CODED GOLD) ARE FOR THE FOLLOWING INDICATIONS: ¿FOR THE FIXATION OF MICROVASCULAR GRAFTS ONLY (EG. FIBULA, RADIUS, SCAPULA, ILIAC CREST) IN A SINGLE-STEP RECONSTRUCTION AFTER RESECTION OF A TUMOR, OSTEOMYELITIS OR OSTEONECROSIS FOR THE INTERNAL FIXATION OF COMMINUTED MANDIBULAR FRACTURES¿. ONE IMAGE HAS BEEN EXEMPLARILY ATTACHED IN THIS REPORT AND CLEARLY SHOWS THAT THE OPERATION IS A SECONDARY RECONSTRUCTION AND THAT NO BONE GRAFT WAS USED FOR THE RECONSTRUCTION (PLEASE SEE IMAGE DOCUMENTATION, FIG. 1). THEREFORE THE ROOT CAUSE OF THE POSTOPERATIVE PLATE FRACTURE CAN BE ATTRIBUTED TO AN OFF LABEL USE. BASED ON STATISTICAL EVALUATION THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. IF THE COMPLAINED DEVICE WILL BE RETURNED AT A LATER DATE, THE COMPLAINT INVESTIGATION WILL BE REOPENED. DEVICE UNABLE TO BE RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT HAD A PARTIAL MANDIBULECTOMY SURGERY INVOLVING THE ASSOCIATED PLATE. HOWEVER IN (B)(6) 2017, DURING A POST-OPERATION INSPECTION, IT WAS FOUND THAT THE PRODUCT HAD FRACTURED AND HALF OF THE BROKEN PLATES ARE STILL IN THE PATIENT'S BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT HAD A PARTIAL MANDIBULECTOMY SURGERY INVOLVING THE ASSOCIATED PLATE. HOWEVER IN (B)(6) 2017, DURING A POST-OPERATION INSPECTION, IT WAS FOUND THAT THE PRODUCT HAD FRACTURED AND HALF OF THE BROKEN PLATES ARE STILL IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581625 PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, RIGHT, 5+17-HOLES, WITH TEMPLATE IMPLANT JEY STRYKER LEIBINGER FREIBURG 1000215218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention